Herbal Composition

ABSTRACT

The invention relates to a herbal composition comprising extracts from  Thuja, Bupleurum, Echinacea, Calendula, Licorice  and  Hypercum;  formulations containing the herbal composition; and use of the herbal composition for alleviating, treating and/or preventing sypmtoms associated with or caused by viral infections

The invention relates to a herbal composition. Specifically, theinvention relates to a herbal composition suitable for alleviating,treating and/or preventing symptoms associated with or caused by viralinfections.

BACKGROUND

The use of plants and plant extracts in the treatment of disease andillness has occurred for centuries. Many of the medicines that are usedtoday originate from early herbal remedies and formulations. Forexample, morphine and codeine are derived from opium poppies, whiletaxol, which is used in the treatment of breast cancer, is derivedoriginally from the Pacific Yew tree.

Viruses are super molecular complexes of nucleic acids, either DNA orRNA, encapsulated in a protein coat. Viruses may infect animal cells andplant cells. Once a virus gains access to the specific host cell, it canalter or manipulate the function of the host cell producing undesirableside effects.

Viruses of the Herpesviridae family of viruses such as Herpes SimplexVirus (HSV), Epstein-Barr Virus (EBV) and Cytomegalo Virus (CMV) areamongst the most common viruses affecting adults and children. Anothercommon family of viruses is the Papovaviridae family of viruses, whichincludes the Human Papilloma Virus (HPV). Coxsackie B virus is also acommon virus, most prominently affecting children.

Herpes viruses (Herpesviridae) are another class of virus common in thegeneral population and include Herpes Simplex Virus (HSV), which causesirritable skin lesions, Epstein-Barr Virus (EBV), which causesinfectious mononucleosis, and Cytomegalo Virus (CMV), which causescytomegalo virus inclusion disease.

There are two different strains of HSV. Herpes simplex virus type 1(HSV-1) is usually associated with infections of the lips, mouth, andface. It is the most common herpes simplex virus among the generalpopulation and is usually acquired in childhood. HSV-1 often causeslesions inside the mouth such as cold sores. Herpes simplex virus 2(HSV-2) is sexually transmitted and is usually associated with genitalulcers or sores.

EBV is most present in adolescent populations in developed countries.Transmission appears to be exposure to EPV-contaminated saliva. Thevirus undergoes a replicated cycle in the oropharyngeal epithelium andthen invades the blood by infecting B cells. The infection manifestsitself by fever, sore throat, and the appearance in the blood ofatypical lymphocytes. For EBV, the treatments include bed rest andtaking analgesic (aspirin) to relieve the fever and headaches.

CMV is primarily a sexually transmitted disease and manifests itself inmononucleosis-like symptoms, which include fever and body aches. In somecases, the virus may be without symptoms at all. People with HIV seem tobe preferentially infected via the eye in the form of CMV retinitis.

Many different types of Human Papilloma Virus (HPV) cause warts, whichare a common epithelial tumor. HPV infects skin cells epithelialkeratinocytes. The viruses replicate in skin cells, causing a variety ofexternal growths. The usual mode of transmission of the virus is by skinto skin inoculation, although it is not well understood how the viruspenetrates and infects cells.

There is often a wide variation in time between infection andmanifestation of visible warts: with common warts from several days toseveral weeks. Genital warts may not appear until more than a year afterinfection. It is believed that some resistance to the manifestation maybe due to cell mediating immune responses.

Current treatments for symptoms of HPV, such as warts, include burningor freezing the infected area of skin. In some instances the infectedarea may be surgically removed. All these treatments can be painful andmay not prevent warts from returning. Generally the current treatmentcan broadly be defined as topical and symptomatic.

The current orthodox methods for treating symptoms of viral infectionsare few and of limited benefit. Therefore, there is a need to provide animproved treatment for symptoms of viral infections or to at leastprovide the public with a useful, alternative choice of treatment.

SUMMARY

According to a first aspect of the invention, there is provided a herbalcomposition comprising extracts from:

-   -   Thuja;    -   Bupleurum;    -   Echinacea;    -   Calendula;    -   Licorice; and    -   Hypericum.

The herbal composition may further comprise extracts of one or more ofManuka, Lycium, Burdock, Cats Claw, Poke root, Ginger, Thyme, Barberry,Golden Seal and Rehmannia, Schisandra, and St Mary's Thistle.

A second aspect of the invention provides a method of alleviating,treating and/or preventing symptoms of skin lesions, sores, cold sores,blisters, warts, lumps, bumps, pimples, rashes and ulcers associatedwith or caused by a viral infection which comprises administering atherapeutically effective amount of the herbal composition as definedabove to a subject in need thereof.

A third aspect of the invention provides use of the herbal compositionas defined above for the manufacture of a medicament to alleviate, treatand/or prevent symptoms of skin lesions, sores, cold sores, blisters,warts, lumps, bumps, pimples, rashes and ulcers associated with orcaused by a viral infection.

A fourth aspect of the invention provides use of the herbal compositionas defined above to alleviate, treat and/or prevent symptoms of skinlesions, sores, cold sores, blisters, warts, lumps, bumps, pimples,rashes and ulcers associated with or caused by a viral infection.

A fifth aspect of the invention provides the herbal composition asdefined above for use in alleviating, treating and/or preventingsymptoms of skin lesions, sores, cold sores, blisters, warts, lumps,bumps, pimples, rashes and ulcers associated with or caused by a viralinfection.

A sixth aspect of the invention provides an agent comprising the herbalcomposition as defined above for alleviating, treating and/or preventingsymptoms of skin lesions, sores, cold sores, blisters, warts, lumps,bumps, pimples, rashes and ulcers associated with or caused by a viralinfection.

The viral infections include, but are not limited to, the Herpesviridaefamily of viruses such as Herpes Simplex Virus (HSV), Epstein-Barr Virus(EBV) and Cytomegalo Virus (CMV); the Papovaviridae family of virusessuch as Human Papilloma Virus (HPV); and the Coxsackie B virus.

The herbal composition may conveniently be administered together withone or more carriers. Thus a seventh aspect of the invention providesthe herbal composition as defined above together with one or morecarriers.

The herbal composition is suitably administered orally and/or topically.

DETAILED DESCRIPTION

In the subject specification, except where the context requiresotherwise due to express language or necessary implication, the words“comprise” or variations such as “comprises” or “comprising” are used inan inclusive sense, i.e. to specify the presence of the stated featuresbut not to preclude the presence or addition of further features invarious embodiments of the invention.

It must be noted that, as used in the subject specification, thesingular forms “a”, “an” and “the” include plural aspects unless thecontext clearly dictates otherwise. Thus, for example, reference to “anextract” includes a single extract, as well as two or more extract; andso forth.

The term “extract” as used herein should be taken in the broadestpossible sense. “Extracts” may include tinctures, fluid extracts orsolid extracts, for example.

In a preferred form of the invention, the extracts are tinctures.Tinctures may be formed from water-based infusions and decoctions.Alternative bases for the extract may include acetracts (to form avinegar extract), glycetracts (to form a glycerine extract), mels (toform a honey extract), oxymels (honey and vinegar), or syrups (to form asugar extract).

Tinctures are prepared by methods well known in the art. Briefly,however, a fresh plant tincture is made by first obtaining a herb driedby air as known in the art. The dried herbs are then further dried in anoven at a temperature of between 60° C. and 70° C. The oven dried herbsare then suspended in a solution in a storage container. In a preferredform, the solution is a mixture of alcohol and water. To make up a 1:5tincture, 75 gms of oven dried herb is suspended in 375 ml of thesolution (weight of herb×5 to get 1:5 ratio) in a storage container. Thestorage container is allowed to stand for about 6 weeks and is shakenperiodically. The mixture is then filtered and the solution withdrawnprovides the tincture used.

Other methods of extracting herbs are well known in the field. Forexample, cold percolation techniques may be used to prepare tinctures.

The tinctures may also be purchased from herbal suppliers such asMediHerb Pty Ltd, 124 McEvoy Street, Warwick, Queensland 4370, Australiain a ready-to-use formulation.

The extracts may be prepared from any part of the herb plant such as,for example, foliage, leaves, the root, flowers, bark, stems or rhisome,seeds, and fruit. However, particular parts of the herb plant areusually used to prepare the extracts.

A Thuja extract is usually made from the foliage. The herbal compositionpreferably comprises from about 0.9% to about 55% of Thuja extract, andmore preferably about 18% of Thuja extract.

A Bupleurum extract is usually made from the root. The herbalcomposition preferably comprises from about 0.9% to about 72% ofBupleurum extract, and more preferably about 18% of Bupleurum extract.

An Echinacea extract is usually made from the root or the whole plant ofthe herb. The herbal composition preferably comprises from about 0.9% toabout 55% of Echinacea extract, and more preferably about 23% ofEchinacea extract.

A Calendula extract is usually made from the flowers. The herbalcomposition preferably comprises from about 0.9% to about 36% ofCalendula extract, and more preferably about 9% of Calendula extract.

A Licorice extract is usually made from the root. The herbal compositionpreferably comprises from about 0.9% to about 36% of Licorice extract,and more preferably about 14% of Licorice extract.

A Hypericum extract is usually made from the flowers. The herbalcomposition preferably comprises from about 1.5% to about 55% ofHypericum extract, and more preferably about 18% of Hypericum extract.

The herbal composition may include one or more different kinds ofextracts. For example, the different herbs may be processed to formextracts by different means. Similarly, the herbal composition maycomprise a mixture of two or more types of extracts of a particularherb.

Table 1 illustrates a herbal composition of a preferred embodiment ofthe invention. TABLE 1 Common Name Approved Name Herb Part PreparationVolume Thuja Thuja occidentalis Foliage 1:5 1-60 ml Bupleurum Bupleurumfalcatum Root 1:2 6-80 ml Echinacea Echinacea purpurea Root 1:2 10-60 mlCalendula Calendula Flower 1:2 1-40 ml officinalis Licorice Glycyrrhizaglabra Root 1:1 1-40 ml Hypericum Hypericum Flower 1:2 2-60 mlperforatum

In addition to the above-mentioned herb extracts, the herbal compositionmay further comprise one or more additional herb extracts, which mayalso assist in alleviating, treating and/or preventing symptoms of skinlesions, sores, cold sores, blisters, warts, lumps, bumps, pimples,rashes and ulcers associated with or caused by viral infections.Examples include herb extracts having anti-viral properties such asManuka, Thyme and Barberry, or properties that stimulate the immunesystem such as Lycium, Burdock, Cats Claw, Poke root, Ginger, GoldenSeal, Rehmannia, Schisandra, and St Mary's Thistle.

Manuka (i.e. Leptospermum scoparium) extract is usually made the leavesof the plant.

A Lycium (i.e. Lycium barbarum) extract is usually made from the fruit.

A Burdock (i.e. Arctium lappa) extract is usually made from the root.

R Cats Claw (i.e. Uncaria tormentosa) extract is usually made from innerbark of the vine.

A Poke root (i.e. Phytolacca decandra) extract is usually made from theroot.

A Ginger (i.e. Zingerber officinale) extract is usually made from theroot or rhizome.

A Thyme (i.e. Thymus spp) is usually made from the leaves of the plant.

A Barberry (i.e. Berberis vulgaris) extract is usually made from theinner bark of the plant.

A Golden Seal (i.e. Hydrastis canadensis) extract is usually made fromthe root or rhizome.

A Rehmannia (i.e. Rehmannia glutinosa) extract is usually made from theroot.

A Schisandra (i.e. Schisandra chinensis) extract is usually made fromthe fruit.

A St Mary's Thistle (e.g. Silybum marianum) extract is usually made fromthe seed.

The herbal composition may comprise from about 0.1% to about 30%, morepreferably from about 0.1% to about 10%, of each of the above-mentionedadditional herb extracts.

The viral infections include, but are not limited to, the Herpesviridaefamily of viruses such as Herpes Simplex Virus (HSV), Epstein-Barr Virus(EBV) and Cytomegalo Virus (CMV); the Papovaviridae family of virusessuch as Human Papilloma Virus (HPV); and the Coxsackie B virus.

Not wishing to be bound by a particular theory or hypothesis theinventor believes that the surprising and unexpected effects seen withthe herbal composition results from synergism between the individualcomponents.

The term “subject” as used herein refers to any animal having symptomsassociated with or caused by viral infections, which requires treatmentwith the herbal composition. The subject may be an animal, such as amammal, preferably a human, or may be a non-human primate ornon-primates such as used in animal model testing. While it isparticularly contemplated that the herbal composition is suitable foruse in medical treatment of humans, it is also applicable to veterinarytreatment, including treatment of companion animals such as dogs andcats, and domestic animals such as horses, ponies, donkeys, mules,llama, alpaca, pigs, cattle and sheep, or zoo animals such as primates,felids, canids, bovids, and ungulates.

Generally, the terms “treating”, “treatment” and the like are usedherein to mean affecting a subject, tissue or cell to obtain a desiredpharmacological and/or physiological effect. The effect may beprophylactic in terms of completely or partially preventing one or moresymptoms of skin lesions, sores, cold sores, blisters, warts, lumps,bumps, pimples, rashes and ulcers associated with or caused by a viralinfection, and/or may be therapeutic in terms of a partial or completecure of one or more symptoms of skin lesions, sores, cold sores,blisters, warts, lumps, bumps, pimples, rashes and ulcers associatedwith or caused by a viral infection. “Treating” as used herein coversany alleviation, treatment, or prevention of one or more symptoms ofskin lesions, sores, cold sore, blisters, warts, lumps, bumps, pimples,rashes and ulcers associated with or caused by a viral infection in ananimal such as a mammal, more particularly a human, and includes:

-   (a) preventing one or more of the symptoms referred to above from    occurring in a subject that may be predisposed to such symptoms, but    has not yet been diagnosed as having the viral infection;-   (b) inhibiting one or more of the symptoms referred to above, i.e.    arresting development of one or more of the symptoms referred to    above; or-   (c) alleviating, relieving or ameliorating the effects, i.e. cause    regression, of one or more of the symptoms referred to above.

As used herein, the term “effective amount” means an amount of theherbal composition to alleviate, treat and/or prevent symptoms of skinlesions, sores, cold sores, blisters, warts, lumps, bumps, pimples,rashes and ulcers associated with or caused by a viral infection inorder to yield a desired therapeutic response. For example, to overcomeor alleviate the effects of one or more of those symptoms.

The term “therapeutically effective amount” means an amount of theherbal composition to yield a desired therapeutic response. For example,alleviating, treating and/or preventing the symptoms of skin lesions,sores, cold sores, blisters, warts, lumps, bumps, pimples, rashes andulcers associated with or caused by a viral infection.

The herbal composition may conveniently be administered together withone or more carriers. Carriers include substances that are useful inpreparing a formulation comprising the herbal composition, may be inco-administration with the composition while allowing the individualcomponents to perform their intended function, and are generally safe,non-toxic and are neither biologically or otherwise undesirable. Inaddition, carriers will include those suitable for veterinarian use aswell as human use. Examples of carriers include dispersing agents,suspending agents, emulsifying agents, stabilising agents, wettingagents, binding agents, lubricants, disintegrants, solvents, media,delay agents, fillers, aqueous and oily bases, non-aqueous vehicles,i.e. edible oils, and the like.

In addition, the herbal composition may contain preserving agents,sweetening agents, colouring agents, flavouring agents, thickeningand/or gelling agents, buffers and the like. Those skilled in the artwill be able to identify further additives that may be desirable forcosmetic reasons, palatability, or shelf life, for example.

As it will be appreciated by those skilled in the art to which theinvention relates, the herbal composition may be converted intocustomary formulations. Examples of formulations include, but are notlimited to, solutions, emulsions, suspensions, powders, granules,natural and synthetic materials impregnated with the individualcomponents of the herbal composition, pills, capsules, tablets, cachets,pastilles, lozenges, bolus, electuary, pastes, ointments, creams,plasters, washes, lotions, transdermal patches, enemas, suppositories,pessaries, sprays (atomiser, or aerosol) mouthwashes, syrups, and/orelixirs. Preferably, the formulation is in the form of a solution or acream. The inventor notes that in the case of warts (HPV infection) suchformulations (i.e. oral solutions and topical creams) are particularlyuseful.

The choice of carriers and/or additives may be dictated to some extentby the intended dosage form of the herbal composition and the mode ofadministration of the herbal composition.

Formulations comprising the herbal composition may be produced by anumber of techniques standard in the art, for example, by mixing theherbal extracts with one or more carriers and/or additives.

Formulations suitable for oral administration may conveniently bepresented in discrete units such as capsules, cachets or tablets eachcontaining a predetermined amount of the herbal composition; as a powderor granules; as a solution, a suspension or as an emulsion. The herbalcomposition may also be presented as a bolus, electuary or paste.Tablets and capsules for oral administration may contain conventionalcarriers such as binding agents, fillers, lubricants, disintegrants, orwetting agents. The tablets may be coated according to methods wellknown in the art. Oral liquid preparations may for example be in theform of aqueous or oily suspensions, emulsions, syrups or elixirs, ormay be presented as a dry product, such as a powder or granules, forconstitution with water or another suitable vehicle, e.g. orange juice,before use. Suitable carriers for such liquid preparations may include,for example, ethyl alcohol, vinegars, glycerine, honey, sugar, or water.Such liquid preparations may also contain conventional additives such assuspending agents, emulsifying agents, non-aqueous vehicles, which mayinclude edible oils, or preservatives.

For topical administration to the skin, the herbal composition may beformulated as ointments, creams, plasters, washes, lotions, or as atransdermal patch. Ointments and creams may, for example, be formulatedwith an aqueous or oily base with the addition of suitable thickeningand/or gelling agents. The Calendula present in the herbal compositionmay also be in the form of an oil infused with Calendula flower.Additionally, an essential oil of Thyme may be present. Lotions andwashes may be formulated with an aqueous or oily base, and will ingeneral also contain one or more emulsifying agents, stabilising agents,dispersing agents, suspending agents, thickening agents, or colouringagents.

Formulations suitable for topical administration in the mouth includelozenges comprising the herbal composition and may have a flavoured basesuch as sucrose and gum acacia or gum tragacanth; pastilles comprisingthe herbal composition in an inert base such as gelatin or sucrose andgam acacia; and mouthwash in a suitable liquid carrier.

In use, the herbal composition would be administered to a subject asneeded, as desired, or as advised by a medical practitioner, pharmacist,attendant physician, medical herbalist, naturopath, or veterinarian. Theselection of the herb extracts may also be made on the specific needs ofthe subject.

As will be appreciated, the dose administered, the period ofadministration, and the general administration regime may differ betweensubjects depending on variables such as their tolerance to certainactive ingredients, weight, metabolism, the mode of administrationchosen, the severity of the symptoms, and the age and/or general healthof the subject. In general, however, a suitable dose of an oralformulation is preferably in the range of from about 1 ml to about 50ml, at least once daily, more preferably from about 6 ml to about 10 ml,at least twice daily, most preferably about 8 ml at least twice daily.Oral treatment may also be supplemented with a topical application.

Treatment is preferably commenced before or at the time symptoms of skinlesions, sores, cold sores, blisters, warts, lumps, bumps, pimples,rashes and ulcers associated with or caused by a viral infection developand preferably continues until such symptoms are no longer present.

The invention will now be further elucidated by reference to thefollowing non-limiting example.

EXAMPLE 1

Study Design

The study was designed for 40 participants.

Participants in the study were selected from the public.

Respondents with any pre-existing health condition that may have beenadversely affected by the herbal composition were excluded from thetrial. These conditions included elevated blood pressure, kidneyinsufficiency, pregnancy, lactation, and epilepsy.

The respondents had a wide range of “skin lumps” that they called warts,including a range of keratoses and some basal cell carcinomas.

After screening the prospective participants, 40 participants werechosen who met the following criteria:

-   -   ages of 18 to 70,    -   having benign warts verified by a medical practitioner; and    -   no serious pre-existing medical condition.

Each of the 40 participants received an individual consultation, withthe principal researcher taking comprehensive medical history notes,including the history of their warts and any previous treatments forthem. Participants had their blood pressure measured and also completeda medical history form.

Participants had their warts photographed, identified by their codenumber placed next to each wart. The scale was determined by placing aruler in the photograph.

Control Group

Of the 40 participants, 20 participants were randomly selected to formthe control group.

The control group had no treatment and at the end of the 12-week trialperiod, each participant in this group had their warts re-photographed.

Treatment Group

The treatment group, which consisted of the remaining 20 participants,took a herbal composition prepared as an oral formulation comprising:

-   -   20 ml of Thuja extract;    -   20 ml of Bupleurum extract;    -   25 ml of Echinacea purpurea extract;    -   10 ml of Calendula extract;    -   15 ml of Licorice extract; and    -   20 ml of Hypericum extract.

The extracts were sourced from MediHerb Pty Ltd of 124 McEvoy Street,Warwick, Queensland 4370, Australia. MediHerb combined the extracts toform the herbal composition. The herbal composition was prepared using apreferred extraction and composition technique (i.e. cold percolationtechnique).

The participants in the treatment group were required to take 8 ml ofthe oral herbal formulations twice daily, with food.

Each participant in the treatment group was also asked to fill in acompliance booklet, with a tick for each dose taken. This data was usedto measure the degree of compliance by the participant.

At the end of the 12-week treatment period, the participants in thetreatment group, as with the control group, were re-photographed.

Participant Withdrawals

By the end of the 12-week treatment period, there were two withdrawalsfrom the treatment group: one woman became pregnant and the other wasnon-compliant. Therefore the relevant data for these two participantswere not collected and are not included in the results. One participantwithdrew from the control group.

Results

The results were measured by a visual comparison of the photographsbefore and after treatment.

Four categories were identified:

No Change

-   -   there was no apparent change in the warts (no patient had an        increase in wart numbers or size);

Partially Cleared

-   -   up to 50% of the warts had been reduced or cleared;

Almost Cleared

-   -   more than 50% of the warts had been reduced or cleared; and

Totally Cleared

-   -   all sign of warts had disappeared.

The results were as follows: Number of Participants Total PartiallyAlmost Totally Completed No Change Cleared Cleared Cleared StudyTreatment 5 6 2 5 18 Control 18 1 0 0 19

It is to be noted that the one participant in the control group who hadany sign of change had been given a medical procedure which helped hisbody's ability to function better, which may have resulted in thespontaneous disappearance of most of his warts.

Adverse Reactions

No adverse reactions or effects were reported.

Statistical Significance of the Results

There was strong evidence of a difference in wart change between the twogroups.

Statistical analysis showed that the probability that the differencesseen between the two groups could have occurred if the effect of thetreatment/no treatment was actually the same was 0.0007—i.e., there isonly a chance of 7 in 10,000 that the effect of the treatment isactually the same (p=0.0007). This illustrates that the herbalcomposition of the present invention appears to show a positive effectfor treatment. A p factor this low shows that it works.

The smaller the p value the more unlikely it is that the effect of thetreatment is the same, meaning the more likely that the effect is real.

It is usually accepted that you need to have a p value of about 0.05 orsmaller to demonstrate that there is a real difference between thetreatments. The result of this trial is almost two orders of magnitudebetter than the basic p value of 0.05 and so there is high level ofconfidence in the effectiveness of the treatment.

Wherein the foregoing description reference has been made to specificcomponent or integers of the invention which known equivalents then suchequivalents are herein incorporated as if individually set forth.

Although this invention has been described by example and with referenceto possible embodiment thereof, it is to be understood thatmodifications or improvements may be made thereto without departing fromthe scope of the invention.

1-37. (canceled)
 38. A herbal composition comprising extracts from:Thuja; Bupleurum; Echinacea; Calendula; Licorice; and Hypericum.
 39. Theherbal composition according to claim 38, wherein the herbal compositioncomprises from about 0.9% to about 55% of Thuja extract.
 40. The herbalcomposition according to claim 38, wherein the herbal compositioncomprises from about 0.9% to about 72% of Bupleurum extract.
 41. Theherbal composition according to claim 38, wherein the herbal compositioncomprises from about 0.9% to about 55% of Echinacea extract.
 42. Theherbal composition according to claim 38, wherein the herbal compositioncomprises from about 0.9% to about 36% of Calendula extract.
 43. Theherbal composition according to claim 38, wherein the herbal compositioncomprises from about 0.9% to about 36% of Licorice extract.
 44. Theherbal composition according to claim 38, wherein the herbal compositioncomprises from about 1.5% to about 55% of Hypericum extract.
 45. Theherbal composition according to claim 38, wherein the herbal compositioncomprises about 18% of Thuja extract.
 46. The herbal compositionaccording to claim 38, wherein the herbal composition comprises about18% of Bupleurum extract.
 47. The herbal composition according to claim38, wherein the herbal composition comprises about 23% of Echinaceaextract.
 48. The herbal composition according to claim 38, wherein theherbal composition comprises about 9% of Calendula extract.
 49. Theherbal composition according to claim 38, wherein the herbal compositioncomprises about 14% of Licorice extract.
 50. The herbal compositionaccording to claim 38, wherein the herbal composition comprises about18% of Hypericum extract.
 51. The herbal composition according to claim38, wherein the herbal composition further comprises extracts of one ormore of Manuka, Lycium, Burdock, Cats Claw, Poke root, Ginger, Thyme,Barberry, Golden Seal and Rehmannia, Schisandra, and St Mary's Thistle.52. The herbal composition according to claim 38, wherein the herbalcomposition further comprises from about 0.1% to about 30% of extractsof one or more of Manuka, Lycium, Burdock, Cats Claw, Poke root, Ginger,Thyme, Barberry, Golden Seal and Rehmannia, Schisandra, and St Mary'sThistle.
 53. The herbal composition according to claim 38, wherein theherbal composition further comprises from about 0.1% to about 10% ofextracts of one or more of Manuka, Lycium, Burdock, Cats Claw, Pokeroot, Ginger, Thyme, Barberry, Golden Seal and Rehmannia, Schisandra,and St Mary's Thistle.
 54. The herbal composition according to claim 38,wherein one or more of the extracts is in the form of a tincture, afluid extract or solid extract, or a mixture thereof.
 55. The herbalcomposition according to claim 38, wherein one or more of the extractsis in the form of a tincture.
 56. The herbal composition according toclaim 55, wherein the tincture is formed from water-based infusions anddecoctions.
 57. The herbal composition according to claim 38, whereinthe base for one or more of the extracts is an acetract to form avinegar extract, a glycetract to form a glycerine extract, a mel to forma honey extract, an oxymel to form a honey and vinegar extract, or asyrup to form a sugar extract.
 58. The herbal composition according toclaim 38, wherein the composition is in an effective amount toalleviate, treat and/or prevent symptoms of skin lesions, sores, coldsores, blisters, warts, lumps, bumps, pimples, rashes and ulcersassociated with or caused by a viral infection.
 59. A herbal formulationcomprising the herbal composition according to claim 38 and one or morecarriers.
 60. The herbal formulation according to claim 59, wherein theherbal formulation is in the form of an oral formulation.
 61. The herbalformulation according to claim 60, wherein the oral formulation is asolution.
 62. The herbal formulation according to claim 59, wherein theherbal formulation is in the form of a topical formulation.
 63. Theherbal formulation according to claim 62, wherein the topicalformulation is a cream.
 64. A method of alleviating, treating and/orpreventing symptoms of skin lesions, sores, cold sores, blisters, warts,lumps, bumps, pimples, rashes and ulcers associated with or caused by aviral infection comprising administering a therapeutically effectiveamount of the herbal composition according to claim 38 to a subject inneed thereof.
 65. The method according to claim 64, wherein the viralinfection is one or more of the Herpes Simplex Virus (HSV), theEpstein-Barr Virus (EBV), the Cytomegalo Virus (CMV), the HumanPapilloma Virus (HPV), or the Coxsackie B virus.
 66. The methodaccording to claim 64, wherein the subject is an animal, mammal orhuman.
 67. The method according to claim 64, wherein the herbalcomposition is in the form of an oral formulation.
 68. The methodaccording to claim 67, wherein from about 1 mL to about 50 mL of theoral formulation is administered at least once daily.
 69. The methodaccording to claim 67, wherein from about 6 mL to about 10 mL of theoral formulation is administered at least twice daily.
 70. The methodaccording to claim 67, wherein about 8 mL of the oral formulation isadministered at least twice daily.
 71. The method according to claim 64,wherein the herbal composition is administered in the form of an oralformulation and as a topical formulation.